FDA Recall Terminated

HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com

Recall: Z-2463-2015 · Initiated July 9, 2015

Recall

Recall Number: Z-2463-2015
Event Number: 71804
Firm: Hardy Diagnostics
FEI Number: 2022807
Product Code: JSO
Status: Terminated
Root Cause: Unknown/Undetermined by firm
Initiated: July 9, 2015
Posted: August 26, 2015
Terminated: November 10, 2015
Address: 1430 W Mccoy Ln, Santa Maria, CA, 93455-1005

Description

Reason

Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the identified lot.

Action

The firm initially notified customers via phone to inform them of a recall. The phone scripts asks customers if they have had any issued with the QC testing. The firm states that our of a precaution they are asking customers to discard the remaining plates of the identified lot, and that credit or replacement plates will be offered for any remaining. The firm followed-up phone calls with a written notification letter. The letter states to complete, sign, and fax or email back the enclosed form stating compliance with the above action. The letters states that is the customer could not be reached via phone and would like replacements or credit to contact the Customer Service Department at 800-266-2222, option 1. Any questions call the Technical Services Department at 800-266-2222, option 2 or email at techservice@hardy diagnostics.com.

Distribution

Distributed in the states of VA, PA, NY, NJ, IL, OH, and MD.

Quantity

2,820 (282 pk/10)